Impact of case manager intervention on psychotic episode recurrence in young adults

Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode. Randomized, Open-label, Multicenter Controlled Study With Blinded Evaluation.

This study tests whether having a trained case manager can help young adults aged 16 to 30 who have had their first psychotic episode avoid having more episodes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 256 (estimated)
• Ages: 16 Years to 30 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (other)
• Locations: 6 sites (Toulouse, Choisir Une Région and 5 other locations)
• Trial ID: NCT05116514 on ClinicalTrials.gov

What this trial studies

This study evaluates how case managers trained in early psychosis care can reduce the recurrence of psychotic episodes in patients aged 16 to 30 who have experienced their first episode. The intervention focuses on personalized support, psycho-education, family involvement, and socio-professional reintegration over a three-year follow-up period. By implementing structured case management, the study aims to improve the overall care paradigm for young individuals facing early psychosis.

Who should consider this trial

Good fit: Ideal candidates are young adults aged 16 to 30 who are experiencing their first psychotic episode and have not previously received antipsychotic treatment.

Not a fit: Patients with chronic psychotic disorders or those who have previously been treated with antipsychotics may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly lower the recurrence rates of psychotic episodes in young patients, leading to better long-term outcomes.

How similar studies have performed: Other studies have shown promising results with case management approaches in early psychosis, suggesting potential for success in this intervention.

Eligibility criteria

Inclusion Criteria:

* The patient or their close relative must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is available for a 3-year follow-up.
* Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by:

  * Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ;
  * Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry);
  * A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features.
* Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.
* At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.

Exclusion Criteria:

* The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
* The subject, or one of the parents for minor patients, refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patients has an IQ less than or equal to 55
* The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition
* The patient is pregnant or breastfeeding

Where this trial is running

Toulouse, Choisir Une Région and 5 other locations

• CHU de TOULOUSE — Toulouse, Choisir Une Région, France (NOT_YET_RECRUITING)
• CH Saint Marie Clermont-Ferrand — Clermont-Ferrand, France (NOT_YET_RECRUITING)
• CHU de Montpellier — Montpellier, France (RECRUITING)
• CHU Nice — Nice, France (NOT_YET_RECRUITING)
• CHU de Nîmes — Nîmes, France (RECRUITING)
• Centre Hospitalier Léon-Jean Grégory — Thuir, France (RECRUITING)

Study contacts

• Principal investigator: Aurélie Schandrin — CHU Nimes
• Study coordinator: Aurélie Schandrin

Conditions: Psychotic Episode